FDA.reportPublic FDA data

CS 7600 Smart Plate

Primary DI
40889971060019
Brand
CS 7600 Smart Plate
Company
CARESTREAM HEALTH, INC.
Model
CS 7600 Smart Plate
Catalog number
1060011
Device description
CS7600 SMART PLATE SIZE 4 V2 - 2 PCS
Published
2016-09-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EAMScreen, intensifying, radiographic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAMScreen, Intensifying, RadiographicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
60889971060013PackageGS120In Commercial Distribution
40889971060019PrimaryGS10
00889971060011Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
6088997106001360889971060013
4088997106001940889971060019
00889971060011008899710600118899710600110889971060011

GMDN Terms#

Term, Definition table
TermDefinition
Digital imaging storage phosphor screenA photostimulatable device used in medical imaging applications that is exposed to radiation by a diagnostic imaging x-ray system to record a patient radiation pattern, and then transferred to a computed radiography scanner to produce a digital image of the latent image formed on the device. The device is transported and shielded from room light by a computed radiography cassette.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature10 Degrees Celsius24 Degrees Celsius

Regulatory Flags#

DUNS number
793169512
Device count
2
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
60889978624188DRX-Compass X-ray SystemDRX-Compass X-ray System86241812022-01-11
60889971739193DRX-Evolution Plus SystemDRX-Evolution Plus System17391922016-09-16
60889978007257DRX-Revolution Mobile X-ray SystemDRX-Revolution Mobile X-ray System80072542016-09-16
60889976565667CARESTREAM DRX-EVOLUTIONCARESTREAM DRX-EVOLUTION65656672016-09-16
40889971067506CS 7200CS 720010675032016-09-16
40889971067513CS 7200CS 720010675112016-09-16
40889971337227CS 7400CS 740013372292016-09-16
40889978214231CS 7400CS 740082142312016-09-16
40889978427969CS 7400CS 740084279652016-09-16
40889978666948CS 7400CS 740086669432016-09-16
60889976579336Vita Flex CR SystemVita Flex CR System65793382019-08-03
60889976579343Vita Flex CR SystemVita Flex CR System65793462019-08-03
60889976579367Vita Flex CR SystemVita Flex CR System65793612019-08-03
60889971746337Vita Flex CR Long Length Imaging SystemVita Flex CR Long Length Imaging System17463382020-05-25
60889971006240Vita LE CR SystemVita LE CR System10062462016-09-16
60889971014306CS 7600CS 760010143072016-09-16
60889971014313CS 7600CS 760010143152016-09-16
60889971023704CS 7600 SLOT PANELCS 7600 SLOT PANEL10237042016-09-16
60889971023711CS 7600 SLOT PANELCS 7600 SLOT PANEL10237122016-09-16
60889971024084Vita CR SystemVita CR System10240822016-10-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00889813062029Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062002Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062019Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
10889813062026Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEAM2024-08-28
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00817169024484Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024491Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024507Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024514Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169024521Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169025016Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-27
00817169023593Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023609Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023616Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023623Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169025009Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
00817169023586Visionary by 3D Dental3D DENTAL DESIGNS AND DEVELOPMENT, LLCEAM2023-01-19
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60889978979547Flexible Phosphor Screen GP-2CARESTREAM HEALTH, INC.EAM2021-06-27
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00843696119638Wolf X-RayFlow X Ray CorporationEAM2020-09-26
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